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Although bosutinib is generally safe and effective, drug-related toxicities (DRTs) such as diarrhea or increased transaminase levels often lead to treatment discontinuation. To clarify whether a lower initial dose of bosutinib (i.e., starting at 200 mg) would reduce rates of discontinuation due to DRTs, we conducted a phase 2 study of BOsutinib Gradual Increase (BOGI trial, UMIN 000032282) as a second/third-line treatment for chronic myeloid leukemia (CML). Between February 4, 2019 and May 24, 2022, 35 patients were enrolled. The rate of bosutinib discontinuation at 12 months was 25.7% vs. 35.9% in a historical control study (Japanese phase 1/2 study) (p = 0.102). The rate of bosutinib discontinuation due to DRTs was significantly lower, at 11.4% vs. 28.2% (p = 0.015). The incidence of grade 3/4 transaminase elevation was 20% vs. 29% (p = 0.427), while the incidence of diarrhea was 3% vs. 25% (p = 0.009). The median dose intensity of bosutinib was higher (391.7 mg/day vs. 353.9 mg/day). Pharmacokinetic analysis of bosutinib showed that patients who achieved a major molecular response tended to have high trough concentrations. Thus, a low initial dose of bosutinib followed by dose escalation reduced discontinuation due to severe DRTs while maintaining high dose intensity and efficacy.
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Objective: The objective of this paper is to reconsider the significance of preoperative chest radiography (CXR) before ophthalmic surgery through investigation of imaging findings and usage status. Methods: This retrospective observational clinical study involved 1616 patients who underwent ophthalmic surgery at Saga University Hospital from 1 January 2019 to 31 December 2020. The patients' radiology reports were obtained from the electronic medical records, and their CXR findings, therapeutic interventions, and progress were investigated. Results: Among all patients, 539 (33.4%) had abnormal preoperative CXR findings. Of these patients, 74 (4.6%) had newly identified abnormal findings. In both patient groups, approximately 70% of patients with abnormal findings were aged ≥70 years, and interstitial shadows were the most common finding. Among all patients with abnormal findings, three (0.19%) received preoperative therapeutic interventions, and all surgeries were performed safely. Forty-three patients with abnormal findings were referred to our hospital or other hospitals for further investigation and treatment postoperatively. Among those patients, eight (0.5%) had primary lung cancer, seven underwent surgery, and one received chemoradiation. The other patients were also followed up and received appropriate therapeutic interventions. Conclusions: Before ophthalmic surgery, few patients required actual therapeutic interventions based on their CXR results. However, many abnormal findings were revealed in elderly patients, including some serious diseases. Furthermore, research has suggested that appropriate therapeutic intervention after ophthalmologic surgery may reduce the risk of a poor life prognosis. This study clearly shows that preoperative CXR is not only useful for perioperative systemic management but also ultimately benefits patients. It is also considered particularly meaningful for patients aged ≥70 years.
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Orthognathic surgery has a high incidence of postoperative nausea (PON) and vomiting (POV), delaying mobility initiation and postoperative recovery. Bleeding is another risk associated with this surgical procedure. We aimed to compare total intravenous anesthesia (TIVA) and volatile anesthesia in patients undergoing orthognathic surgery in terms of postoperative nausea and vomiting (PONV) incidence and hemodynamic changes. This retrospective study included 82 patients who underwent bilateral sagittal split ramus osteotomies at Saga University Hospital between April 2016 and April 2021. We compared the effects of TIVA and volatile anesthesia on PONV onset after surgery, acute postoperative hemodynamic changes (blood pressure and heart rate), and factors contributing to PONV. PON was significantly lower in the TIVA group than in the volatile anesthesia group. The total dose of fentanyl contributed to the onset of POV, while the onset of PON was associated with low volumes of fluid infusion and urine in the TIVA and volatile anesthesia groups, respectively. Furthermore, post-extubation hemodynamic change was significantly smaller in the TIVA group than in the volatile anesthesia group. Therefore, TIVA could have a reduced risk of PONV and hemodynamic changes in patients undergoing orthognathic surgery. Employing TIVA could mitigate perioperative complications and enhance patient safety.
Subject(s)
Anesthesia, General , Anesthesia, Intravenous , Orthognathic Surgical Procedures , Postoperative Nausea and Vomiting , Humans , Female , Male , Retrospective Studies , Adult , Anesthesia, Intravenous/adverse effects , Anesthesia, Intravenous/methods , Anesthesia, General/adverse effects , Anesthesia, General/methods , Postoperative Nausea and Vomiting/epidemiology , Postoperative Nausea and Vomiting/etiology , Orthognathic Surgical Procedures/adverse effects , Orthognathic Surgical Procedures/methods , Postoperative Complications/etiology , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , Orthognathic Surgery/methods , Young Adult , Anesthesia, Inhalation/adverse effects , Anesthesia, Inhalation/methods , Hemodynamics/drug effects , Anesthetics, Intravenous/administration & dosage , Anesthetics, Intravenous/adverse effects , Osteotomy, Sagittal Split Ramus/adverse effects , Osteotomy, Sagittal Split Ramus/methods , Fentanyl/administration & dosage , Fentanyl/adverse effectsABSTRACT
OBJECTIVES: This study aimed to investigate the impact of memory function and social capital on depressive symptoms during the COVID-19 pandemic among older adults in rural Japan. METHODS: A retrospective study with longitudinal data was conducted during COVID-19 from May 2021 to November 2021 (T2) in Kurogawa, Japan. The candidate population for this study was 145 with the following requirements: (1) older individuals aged 65 years or above who were registered in the Kurogawa study, and (2) those with previous data (from November 2016 to February 2020; T1 as pre-pandemic). Memory function was assessed using the Wechsler Memory Scale-Revised Logical Memory II delayed recall part A (LM II-DR). Depressive symptoms were assessed using the Japanese version of the 15-item Geriatric Depression Scale (GDS-15). Social capital was evaluated through civic participation, social cohesion, and reciprocity. Fear of the COVID-19 infection (FCV-19S) was evaluated. RESULTS: The final analysis included 96 participants (mean age = 81.0 years, SD = 4.8) Multivariate analysis for GDS-15 score by Mixed Model Repeated Measures (MMRM) revealed significant associations between LM II-DR (ß = -0.13, 95% CI: -0.21-0.05, p = 0.002) and FCV-19S during COVID-19 (ß = 0.08, 95% CI: 0.01-0.15, p = 0.02) with GDS-15 score. However, civic participation, social cohesion and reciprocity were not associated with GDS-15 score. CONCLUSIONS: Among older adults in rural Japan, memory function and fear of the COVID-19 infection were significantly associated with depressive symptoms in MMRM analysis. However, social capital was not associated with depressive symptoms. This highlights the need to address memory function and fear of the COVID-19 infection in interventions for older adults during crises like the COVID-19 pandemic.
Subject(s)
COVID-19 , Depression , Independent Living , Rural Population , Social Capital , Humans , COVID-19/psychology , COVID-19/epidemiology , Female , Male , Japan/epidemiology , Aged , Retrospective Studies , Aged, 80 and over , Longitudinal Studies , Rural Population/statistics & numerical data , Depression/epidemiology , Depression/psychology , SARS-CoV-2ABSTRACT
INTRODUCTION: The objective of the current study was to investigate the association between lower body bone fractures occurring during maintenance hemodialysis and prognosis. METHODS: This study included 151 hemodialysis patients at the dialysis center of our hospital as of December 2017, and data were systematically gathered from medical records over a period of 5 years, concluding in December 2022. RESULTS: Fourteen patients, 3.0 per 100 person-years, in 151 hemodialysis patients suffered from lower body bone fractures. The ratio of males was significantly lower, and age was significantly higher in the lower body bone fracture group than in the no lower body bone fracture group. Duration of hemodialysis prior to entry into this study was significantly shorter in the lower body bone fracture group than in the no lower body bone fracture group. Serum albumin was significantly lower and alkaline phosphatase was significantly higher in the lower body bone fracture group than in the no lower body bone fracture group. Mortality rate was significantly higher in the lower body bone fracture group (85.7%) compared to no lower body bone fracture group (28.5%) (p = 0.01). Kaplan-Meier survival curves for mortality showed that lower body bone fracture group had poor prognosis compared to no lower body bone fracture group. Multivariable-adjusted odds ratio for mortality were significantly higher for cases with lower body bone fractures. CONCLUSION: Lower body bone fractures have high mortality rates and poor prognosis in the patients with hemodialysis.
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BACKGROUND: Dual-energy computed tomography (DE-CT) can differentiate between hemorrhage and iodine contrast medium leakage following mechanical thrombectomy (MT) for acute ischemic stroke (AIS). We determined whether subarachnoid hemorrhage (SAH) and subarachnoid iodine leakage (SAIL) on DE-CT following MT were associated with malignant brain edema (MBE). METHODS: We analyzed the medical records of 81 consecutive anterior circulation AIS patients who underwent MT. SAH or SAIL was diagnosed via DE-CT performed immediately after MT. We compared the procedural data, infarct volumes, MBE, and modified Rankin scale 0-2 at 90 days between patients with and without SAH and between patients with and without SAIL. Furthermore, we evaluated the association between patient characteristics and MBE. RESULTS: A total of 20 (25%) patients had SAH and 51 (63%) had SAIL. No difference in diffusion-weighted imaging (DWI)-infarct volume before MT was observed between patients with and without SAH or patients with and without SAIL. However, patients with SAIL had larger DWI-infarct volumes 1 day following MT than patients without SAIL (95 mL vs 29 mL; p=0.003). MBE occurred in 12 of 81 patients (15%); more patients with SAIL had MBE than patients without SAIL (22% vs 3%; p=0.027). Severe SAIL was significantly associated with MBE (OR, 12.5; 95% CI, 1.20-131; p=0.006), whereas SAH was not associated with MBE. CONCLUSION: This study demonstrated that SAIL on DE-CT immediately after MT was associated with infarct volume expansion and MBE.
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We conducted a retrospective case-control study to assess the efficacy of personalized health guidance interventions on individuals with type 2 diabetes mellitus and obesity. A selection was made of individuals in regular visits to the Takagi Hospital for medical checkups between January 2017, and October 2021. Totally, 108 subjects (cases) with health guidance were divided into 2 groups: one group without pharmacotherapy for diabetes mellitus in medical institutions (nâ =â 92) and another group with pharmacotherapy (nâ =â 116). Cases were provided with personalized health guidance interventions by public health nurses for 30â min, in accordance with the Japanese clinical guidelines for the prevention of lifestyle-related diseases. Sex- and age-matched controls were chosen from individuals with diabetes mellitus without health guidance. The intervention without pharmacotherapy resulted in improvements in health indicators, including body weight, waist circumference, diastolic blood pressure, triglyceride levels, and γ-glutamyl trans-peptidase. These positive effects were not observed in the control group without health guidance. The therapeutic effects of health guidance were observed in cases where pharmacotherapy was administered. In conclusion, the implementation of individual health guidance interventions may prove to be effective for individuals with type 2 diabetes mellitus and obesity who regularly attend medical checkups.
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Gastrointestinal bleeding is one serious complication of patients undergoing hemodialysis with end-stage renal failure. The present study aimed to evaluate risks and clinical features of real-world clinical data on upper and lower gastrointestinal bleeding in patients undergoing hemodialysis during a 5-year longitudinal observation period. This study included 151 patients undergoing maintenance hemodialysis at Takagi Hospital between December 2017 and December 2022. Clinical data from December 2017 were recorded, and upper and lower gastrointestinal bleeding, mortality, prescribed medications, and bone fractures were examined during the five-year observation period. Of 151 patients, 32 (21.2%:4.2% per year) experienced bleeding, 24 had upper gastrointestinal bleeding, 7 had lower gastrointestinal bleeding, and one had an unknown origin of bleeding. Ulcers or erosions primarily cause upper gastrointestinal bleeding without Helicobacter pylori infection, whereas patients with H pylori eradication are more likely to experience bleeding caused by vascular lesions, often accompanied by underlying comorbidities. The prophylactic effects of proton pump inhibitors and histamine-2 receptor blockers were limited in hemodialysis patients, as 15 out of 24 patients with upper gastrointestinal bleeding (62.5%) were prescribed these medications. The mortality rate in patients with lower gastrointestinal bleeding (71.4%) was higher than that in those without bleeding (33.6%) (Pâ <â .05). All patients with lower gastrointestinal bleeding were prescribed nonsteroidal anti-inflammatory drugs and/or aspirin. In this study, endoscopic hemostasis was successfully achieved. The present study indicated that the incidence of gastrointestinal bleeding during hemodialysis was relatively high. Upper gastrointestinal bleeding may develop even with the prescription of proton pump inhibitors. Lower gastrointestinal bleeding was a complication in hemodialysis patients under serious pathological condition with nonsteroidal anti-inflammatory drugs and or aspirin.
Subject(s)
Helicobacter Infections , Helicobacter pylori , Kidney Failure, Chronic , Humans , Proton Pump Inhibitors/therapeutic use , Follow-Up Studies , Helicobacter Infections/drug therapy , Gastrointestinal Hemorrhage/etiology , Gastrointestinal Hemorrhage/chemically induced , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Aspirin/therapeutic use , Kidney Failure, Chronic/complications , Kidney Failure, Chronic/therapy , Kidney Failure, Chronic/chemically induced , Renal Dialysis/adverse effectsABSTRACT
OBJECTIVE: This study was performed to evaluate whether the use of CAD EYE (Fujifilm, Tokyo, Japan) for colonoscopy improves colonoscopy quality in gastroenterology trainees. METHODS: The patients in this multicenter randomized controlled trial were divided into Group A (observation using CAD EYE) and Group B (standard observation). Six trainees performed colonoscopies using a back-to-back method in pairs with gastroenterology experts. The primary end-point was the trainees' adenoma detection rate (ADR), and the secondary end-points were the trainees' adenoma miss rate (AMR) and Assessment of Competency in Endoscopy (ACE) tool scores. Each trainee's learning curve was evaluated using a cumulative sum (CUSUM) control chart. RESULTS: We analyzed data for 231 patients (Group A, n = 113; Group B, n = 118). The ADR was not significantly different between the two groups. Group A had a significantly lower AMR (25.6% vs. 38.6%, P = 0.033) and number of missed adenomas per patient (0.5 vs. 0.9, P = 0.004) than Group B. Group A also had significantly higher ACE tool scores for pathology identification (2.26 vs. 2.07, P = 0.030) and interpretation and identification of pathology location (2.18 vs. 2.00, P = 0.038). For the CUSUM learning curve, Group A showed a trend toward a lower number of cases of missed multiple adenomas by the six trainees. CONCLUSION: CAD EYE did not improve ADR but decreased the AMR and improved the ability to accurately locate and identify colorectal adenomas. CAD EYE can be assumed to be beneficial for improving colonoscopy quality in gastroenterology trainees. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (UMIN000044031).
Subject(s)
Adenoma , Colonic Polyps , Colorectal Neoplasms , Humans , Artificial Intelligence , Prospective Studies , Clinical Competence , Colonoscopy/methods , Colorectal Neoplasms/diagnosis , Adenoma/diagnosis , Adenoma/pathology , Colonic Polyps/diagnosisABSTRACT
BACKGROUND: Ozone is one of the triggers of asthma, but its impact on the pathophysiology of asthma, such as via airway inflammation and airway hyperresponsiveness (AHR), is not fully understood. Thymic stromal lymphopoietin (TSLP) is increasingly seen as a crucial molecule associated with asthma severity, such as corticosteroid resistance. METHODS: Female BALB/c mice sensitized and challenged with house dust mite (HDM) were exposed to ozone at 2 ppm for 3 h. Airway inflammation was assessed by the presence of inflammatory cells in bronchoalveolar lavage fluid and concentrations of cytokines including TSLP in lung. Anti-TSLP antibody was administered to mice to block the signal. Survival and adhesion of bone marrow-derived eosinophils in response to granulocyte colony-stimulating factor (G-CSF) were evaluated. RESULTS: Ozone exposure increased eosinophilic airway inflammation and AHR in mice sensitized and challenged with HDM. In addition, TSLP, but not IL-33 and IL-25, was increased in lung by ozone exposure. To confirm whether TSLP signaling is associated with airway responses to ozone, an anti-TSLP antibody was administered, and it significantly attenuated eosinophilic airway inflammation, but not AHR. Interestingly, G-CSF, but not type 2 cytokines such as IL-4, IL-5, and IL-13, was regulated by TSLP signaling associated with eosinophilic airway inflammation, and G-CSF prolonged survival and activated eosinophil adhesion. CONCLUSIONS: The present data show that TSLP contributes to ozone-induced exacerbations of eosinophilic airway inflammation and provide greater understanding of ozone-induced severity mechanisms in the pathophysiology of asthma related to TSLP and G-CSF.
Subject(s)
Asthma , Thymic Stromal Lymphopoietin , Animals , Female , Mice , Cytokines , Granulocyte Colony-Stimulating Factor , Inflammation , Mice, Inbred BALB CABSTRACT
PURPOSE: To customize a passive surgery support robot for ophthalmic surgery and preliminarily evaluate its performance. STUDY DESIGN: Prospective observational study. METHODS: The range of motion of the arm was analyzed during ophthalmic surgery and, based on this analysis, a commercially available passive robot was customized for surgical support for ophthalmic surgery; following which a prototype robot was constructed. To examine the effects on the brachial muscle during surgical operations with and without the prototype robot, surface electromyograms of the biceps and triceps were analyzed after performing continuous curvilinear capsulorrhexis (CCC) and suturing the sclerocorneal wound in a cataract surgery simulation. Six surgeons performed cataract surgery, and the degree of arm stability and muscle fatigue during surgery were evaluated using a visual analog scale. RESULTS: During surgery, the prototype robot enabled fixation of the elbow and wrist at any position within the surgeon's range of motion, expanding the range of motion of the hand and fingers and stabilizing operability. Surface electromyography showed a significant decrease in the mean amplitude value of the biceps brachii during both CCC and suturing (p < 0.0001). No significant difference was observed in the triceps brachii. The arm stability and muscle fatigue were improved by 83.3% on the visual analog scale with the prototype robot compared with that without protpotype robot. CONCLUSION: The use of a passive prototype robot may improve arm stability and reduce muscle fatigue during ophthalmic surgery.
Subject(s)
Cataract , Robotics , Humans , Muscle, Skeletal/physiology , Arm/physiology , ElectromyographyABSTRACT
INTRODUCTION: Bronchodilators, including long-acting muscarinic antagonists (LAMA) and long-acting beta 2 agonists (LABA), are the main treatments for chronic obstructive pulmonary disease (COPD). The efficacy of triple therapy (inhaled corticosteroids/LAMA/LABA) has also been reported. However, the effect of triple therapy on patients with mild-to-moderate COPD has not yet been clarified. This study aims to investigate the safety and efficacy of triple therapy, compared with LAMA/LABA combination therapy, for lung function and health-related quality of life in patients with mild-to-moderate COPD and identify baseline characteristics and biomarkers to predict responders and non-responders to triple therapy. METHODS AND ANALYSIS: This is a multicentre, prospective, open-label, randomised, parallel-group study. Mild-to-moderate patients with COPD will be randomised to receive fluticasone furoate/umeclidinium/vilanterol or umeclidinium/vilanterol for 24 weeks. A total of 668 patients will be enrolled from March 2022 to September 2023 from 38 sites in Japan. The primary endpoint is the change in the trough forced expiration volume in 1 s after 12 weeks of treatment. Secondary endpoints are responder rates based on the COPD assessment test score and the St. George's Respiratory Questionnaire total score after 24 weeks of treatment. The safety endpoint is the occurrence of any adverse events. We will also investigate safety in terms of changes in microbial colonisation in sputum and antimycobacterium avium complex antibodies. ETHICS AND DISSEMINATION: The study protocol and informed consent documents were approved by the Saga University Clinical Research Review Board (approval number: CRB7180010). Written informed consent will be obtained from all patients. Recruitment of the patients began in March 2022. The results will be disseminated through scientific peer-reviewed publications and domestic and international medical conferences. TRIAL REGISTRATION NUMBERS: UMIN000046812 and jRCTs031190008.
Subject(s)
Pulmonary Disease, Chronic Obstructive , Quality of Life , Humans , Prospective Studies , Administration, Inhalation , Nebulizers and Vaporizers , Muscarinic Antagonists/adverse effects , Pulmonary Disease, Chronic Obstructive/drug therapy , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
The present retrospective study aimed to examine the real-world data regarding time-dependent changes in the age distribution of patients with coronavirus disease 2019 (COVID-19) as well as the severity and infectivity in a regional core hospital in Japan. Patients with COVID-19 who visited the fever outpatient branch in Takagi Hospital during phase I (May 1 to December 31, 2021), and during phase II (January 1 to April 30, 2022) were evaluated. The age distribution of outpatients and the characteristics of inpatients aged > 75 years were compared between phases I and II. The age distribution of outpatients shifted from the older generation in phase I to the younger generation in phase II (p < 0.01). Disease severity might be reduced in a time-dependent manner with a decrease in the hospitalization rate (phase I: 145/368 (39.4%); phase II: 104/1496 (7.0%); p < 0.01) and mortality rate (phase I: 10/368 (2.7%); phase II: 7/1496 (0.5%); p < 0.01). The number of patients increased in phase II (374.0/month) compared to that in phase I (36.8/month). Regarding the older inpatients, the disease severity of COVID-19 and hospitalization days were reduced in phase II compared to those in phase I (p < 0.01, each). In conclusion, the present study suggests a change in the age distribution of patients with COVID-19, a decrease in toxicity, and an increase in infectivity of severe acute respiratory syndrome coronavirus 2 in a time-dependent manner.
Subject(s)
COVID-19 , Humans , Age Distribution , Retrospective Studies , Japan , Hospitals , Patient AcuityABSTRACT
INTRODUCTION: Obesity is associated with severe asthma, but no specific treatment has been established. The gut microbiome is increasingly recognized as a crucial factor, but specific treatments focused on the gut microbiome have not been established. Recently, azithromycin has been found to have the capacity to attenuate exacerbations, a characteristic of severe asthma. The effect of azithromycin on obesity-induced severe asthma is not understood. METHODS: The purpose of the present study is to clarify the effect of azithromycin on exacerbations in asthmatic patients with obesity. To explore the mechanism, the gut microbiome, metabolites of microbes such as short-chain fatty acids, and blood inflammatory cytokines will be analyzed to evaluate the correlation with the effect of azithromycin on exacerbations in obesity-induced severe asthma. A multi-center, prospective, single-arm intervention study is planned. DISCUSSION: The present study will allow us to evaluate the effect of azithromycin on exacerbations, particularly in asthma patients with obesity, and explore biomarkers, targeting molecules including the gut microbiome, which are correlated with decreased exacerbations. The present results could contribute to identifying new therapeutic prospects and targeted microbes or molecules associated with severe clinical characteristics in asthmatic patients with obesity. TRIAL REGISTRATION: This study has been registered as a prospective study with the University Hospital Medical Information Network (UMIN0000484389) and the Japan Registry of Clinical Trials (jRCTs071220023).
Subject(s)
Asthma , Azithromycin , Humans , Azithromycin/therapeutic use , Prospective Studies , Double-Blind Method , Asthma/drug therapy , Obesity/complications , Obesity/drug therapy , Anti-Bacterial Agents/therapeutic use , Multicenter Studies as TopicABSTRACT
Regulatory T cells (Tregs) suppress the activation and subsequent effector functions of CD4 effector T cells (Teffs). However, molecular mechanisms that enforce Treg-mediated suppression in CD4 Teff are unclear. We found that Tregs suppressed activation-induced global protein synthesis in CD4 Teffs prior to cell division. We analyzed genome-wide changes in the transcriptome and translatome of activated CD4 Teffs. We show that mRNAs encoding for the protein synthesis machinery are regulated at the level of translation in activated CD4 Teffs by Tregs. Tregs suppressed global protein synthesis of CD4 Teffs by specifically inhibiting mRNAs of the translation machinery at the level of mTORC1-mediated translation control through concerted action of immunosuppressive cytokines IL-10 and TGFß. Lastly, we found that the therapeutic targeting of protein synthesis with the RNA helicase eIF4A inhibitor rocaglamide A can alleviate inflammatory CD4 Teff activation caused by acute Treg depletion in vivo. These data show that peripheral tolerance is enforced by Tregs through mRNA translational control in CD4 Teffs.
Subject(s)
CD4-Positive T-Lymphocytes , T-Lymphocytes, Regulatory , Lymphocyte Activation , Cytokines/metabolism , Transforming Growth Factor beta/metabolism , RNA, Messenger/genetics , RNA, Messenger/metabolismABSTRACT
Objective We analyzed adverse events retrospectively during a three-year follow-up of patients undergoing hemodialysis at the dialysis center of our general hospital that can treat comprehensive diseases and conducted an exploratory study focusing on the risk factors that determine the prognosis of hemodialysis patients. Methods A total of 132 hemodialysis patients at our dialysis center as of June 2017 were included in the study. Data on event incidence, including death and various clinical indicators, were collected in the electronic medical record for three years until June 2020. Results Between June 2017 and June 2020, 33 of the 132 patients died. The mortality group had a lower body mass index (BMI) and a longer duration of hemodialysis already carried out with more preexisting upper gastrointestinal (GI) bleeding, infections, ischemic heart disease (IHD), and malignancy than the survival group. Furthermore, the mortality group took more warfarin, aspirin, proton pump inhibitors and less H2 blockers than the survival group. Occurrence of upper or lower GI bleeding was similar between the mortality and survival groups. In a univariate analysis for mortality, the odds ratio was significantly higher for a low BMI (<18), long duration of hemodialysis, history of upper GI bleeding, and presence of IHD. Multivariable-adjusted odds ratios for mortality were significantly higher for cases with a history of upper GI bleeding and BMI <18. Conclusion A history of upper GI bleeding and low BMI may be poor prognostic factors of hemodialysis patients. Careful management of upper GI bleeding and a low BMI are required during the initiation of hemodialysis.
Subject(s)
Gastrointestinal Hemorrhage , Hospitals, General , Humans , Retrospective Studies , Gastrointestinal Hemorrhage/epidemiology , Gastrointestinal Hemorrhage/therapy , Risk Factors , Renal DialysisABSTRACT
We retrospectively analyzed major cardiovascular events (MACE), a composite of cardiac death, nonfatal myocardial infarction, unplanned revascularization, heart failure leading to hospitalization, and stroke during a 3-year follow-up of patients with hemodialysis at the dialysis center of our general hospital that can treat comprehensive diseases. Moreover, we conducted an exploratory study that focuses on the risk factor for MACE in patients with hemodialysis.A total of 132 patients with hemodialysis at our dialysis center as of June 2017 were included in the study. Data on event incidence, including death and various clinical indicators, were collected in the electronic medical record for three years until June 2020. Between June 2017 and June 2020, of the 132 patients with hemodialysis, 31 patients experienced MACE (10 cardiovascular deaths, 3 nonfatal myocardial infarction, 11 unplanned revascularizations, 5 heart failure leading to hospitalization, and 2 stroke). The patients with MACE had a lower body mass index (BMI), longer duration of dialysis with more preexisting gastrointestinal (GI) bleeding, and took more aspirin compared to the MACE-free patients. Malnutrition markers (serum total protein, serum albumin, and serum total cholesterol) were similar in both groups. In a univariate analysis for MACE, the odds ratio was significantly higher for BMI < 18.5, duration of hemodialysis, and history of GI bleeding. Multivariable-adjusted odds ratios for MACE were significantly higher for BMI < 18.5.In conclusion, BMI < 18.5 without malnutrition may be an independent risk factor for MACE in patients with hemodialysis.
Subject(s)
Cardiovascular Diseases , Heart Failure , Malnutrition , Myocardial Infarction , Stroke , Albumins , Aspirin , Blood Proteins , Body Mass Index , Cardiovascular Diseases/complications , Cardiovascular Diseases/etiology , Cholesterol , Heart Failure/complications , Heart Failure/epidemiology , Humans , Malnutrition/complications , Malnutrition/epidemiology , Myocardial Infarction/complications , Renal Dialysis/adverse effects , Retrospective Studies , Risk Factors , Stroke/epidemiology , Stroke/etiologyABSTRACT
Background and Aim: The present study aimed to compare the utility and safety of the colonic self-expandable metallic stent between patients with obstructive primary colorectal cancer who underwent chemotherapy or palliative treatment care and patients bridging for surgery. Methods: The cases of 71 patients with colonic obstructive stenosis and in-dwelling stents who were hospitalized between May 2012 and April 2020 at Karatsu Red Cross Hospital were retrospectively analyzed. The patients were classified into three groups: bridging for curative surgery (group I), receiving systemic chemotherapy (group II-A), and receiving only palliative treatment (group II-B). Technical and clinical success rates and complication rates after stenting were evaluated. Results: No significant differences were observed in the technical (procedure) success rates (group I: 100%; group II, 97.6% [II-A: 100%; II-B: 95.8%]). The total clinical success rate was 85.9% (61/71) and did not vary significantly among the groups (group I: 82.8%; group II 88.0% [II-A: 83.3%; II-B: 91.6%]). No significant differences were observed in the early complication rates between groups I and II and in the late complication rates between groups II-A and II-B. Nutrition status, general condition, tumor staging, and 1-year survival were poorer in group II than in group I. Conclusion: The findings show that colonic stenting for malignant obstruction was performed successfully and safely both in patients who received systemic chemotherapy or palliative therapy and in patients bridging for curative surgery, regardless of risk status for malnutrition, poor general condition, cancer stage progression, and short survival.
ABSTRACT
Sodium glucose cotransporter-2 inhibitors (SGLT2is) are now widely used to treat diabetes, but their effects on nonalcoholic fatty liver disease (NAFLD) remain to be determined. We aimed to evaluate the effects of SGLT2is on the pathogenesis of NAFLD. A multicenter, randomized, controlled trial was conducted in patients with type 2 diabetes with NAFLD. The changes in glycemic control, obesity, and liver pathology were compared between participants taking ipragliflozin (50 mg/day for 72 weeks; IPR group) and participants being managed without SGLT2is, pioglitazone, glucagon-like peptide-1 analogs, or insulin (CTR group). In the IPR group (n = 25), there were significant decreases in hemoglobin A1c (HbA1c) and body mass index (BMI) during the study (HbA1c, -0.41%, P < 0.01; BMI, -1.06 kg/m2 , P < 0.01), whereas these did not change in the CTR group (n = 26). Liver pathology was evaluated in 21/25 participants in the IPR/CTR groups, and hepatic fibrosis was found in 17 (81%) and 18 (72%) participants in the IPR and CTR groups at baseline. This was ameliorated in 70.6% (12 of 17) of participants in the IPR group and 22.2 % (4 of 18) of those in the CTR group (P < 0.01). Nonalcoholic steatohepatitis (NASH) resolved in 66.7% of IPR-treated participants and 27.3% of CTR participants. None of the participants in the IPR group developed NASH, whereas 33.3% of the CTR group developed NASH. Conclusion: Long-term ipragliflozin treatment ameliorates hepatic fibrosis in patients with NAFLD. Thus, ipragliflozin might be effective for the treatment and prevention of NASH in patients with diabetes, as well as improving glycemic control and obesity. Therefore, SGLT2is may represent a therapeutic choice for patients with diabetes with NAFLD, but further larger studies are required to confirm these effects.
Subject(s)
Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/drug therapy , Glucosides/therapeutic use , Non-alcoholic Fatty Liver Disease/complications , Non-alcoholic Fatty Liver Disease/drug therapy , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use , Thiophenes/therapeutic use , Aged , Body Mass Index , Diabetes Mellitus, Type 2/blood , Female , Glycated Hemoglobin/metabolism , Glycemic Control , Humans , Male , Middle Aged , Non-alcoholic Fatty Liver Disease/pathologyABSTRACT
BACKGROUND AND AIM: Elobixibat is a novel ileal bile acid transporter inhibitor. This study aimed to compare the efficacy, tolerability, and safety of the combination of elobixibat and 1 L of polyethylene glycol formulation containing ascorbic acid (PEG-Asc) solution versus the combination of sodium picosulfate and 1-L PEG-Asc solution as bowel preparation for colonoscopy. METHODS: This multi-center, randomized, observer-blinded, non-inferiority study recruited 210 outpatients who were assigned to either the elobixibat plus 1-L PEG-Asc group (group A) or the sodium picosulfate plus 1-L PEG-Asc group (group B). The quality of the bowel cleansing level was assessed by the Boston Bowel Preparation Scale (BBPS) and compared the bowel cleansing level between the groups. Data regarding bowel preparation time, patients' tolerability, and adverse events were also analyzed. RESULTS: Data for 196 patients (99 in group A and 97 in group B) were analyzed finally. BBPS was comparable between group A and B (8.3 ± 0.9 vs. 8.3 ± 0.7; P = 0.88). Consequently, the adequate bowel preparation rate in groups A and B was 95.0% and 99.0%, respectively (-4.0%, 95% CI -9.3 to 1.5). Bowel preparation time in group A was similar to that in group B (348.2 ± 79.8 min vs. 330.8 ± 82.5 min; P = 0.13), whereas, sleep disturbance was significantly less frequent in group A than in group B (10.2% vs. 22.7%; P = 0.02). CONCLUSIONS: The combination of elobixibat and 1-L PEG-Asc can be considered an alternative bowel preparation for colonoscopy considering the equivalent bowel cleansing effect and less frequent sleep disturbance. The Japan Registry of Clinical Trials (jRCTs41180026).